Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

Phase 1

Completed

• Conditions: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia
• Interventions: Biological: CD34-positive cells; Biological: Saline and 5% autologous plasma

• Registration Number: NCT00616980
• Lead Sponsor: Losordo, Douglas, M.D.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Primary Completion: 2010-04
• Study Completion: 2010-08
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 21-80 years of age
• moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
• unsuitable for conventional revascularization

Exclusion Criteria

• advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
• advance AV block or NYHA Class III or Class IV heart failure
• myocardial infarction within 3 months of treatment
• successful coronary or lower extremity revascularization within 3 months of study enrollment
• arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
• co-morbidity associated with life expectancy of less than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	CD34-positive cells	-
High Dose	CD34-positive cells	-
Saline	Saline and 5% autologous plasma	-

Primary Outcome Measures

Name	Time	Method
Limb Salvage	6 months
Safety of Intramuscular Injection of CD34-positive cells	6 months and 1 year
Change in Rest Pain	6 months
Ulcer Healing	6 months
Functional Improvement	6 months

Secondary Outcome Measures

Name	Time	Method
Disease Severity	6 months
Assessment of Co-morbidity	6 months

Trial Locations

Locations (12)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Florida Research Network LLC; 🇺🇸 Gainsville, Florida, United States

Cardiology, PC; 🇺🇸 Birmingham, Alabama, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Mount Sinai School of Medicine Division of Vascular Surgery; 🇺🇸 New York, New York, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University Hospitals of Cleveland, Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Utah-Vascular Surgery Division; 🇺🇸 Salt Lake City, Utah, United States

Comprehensive Cardiovascular Care St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States